planned to compare dieting with non-dieting approach in weight management group [ Time Frame: 6 months and 1 year ]

Estimated Enrollment:

200

Study Start Date:

May 2002

Study Completion Date:

February 2007

Primary Completion Date:

October 2006 (Final data collection date for primary outcome measure)

Detailed Description:

Patients are randomized (2:1) to either the intensive or standard treatment (control). Those who get randomized into the intensive group go to a family-based weight management program, including exercise, nutrition, behavior modification, and parenting classes. The intensive group is further randomized into a diet or non-dieting class to compare the outcomes of two different nutrition intervention methods. These classes meet twice per week (exercise twice per week and nutrition/behavior modification once per week)for first six months and then only twice per month during last six months. An exercise physiologist supervises the exercise component, which involves 45 minutes of aerobic activity (targeted at 65 to 80 percent of the subject's estimated maximum heart rate. A registered dietitian facilitates the nutrition and behavior component. A social worker facilitates parent classes when the children have a behavior modification topic in their class (parents only attend nutrition sessions). Those who get randomized into the control group go to clinic visits every 6 months. Intervention subjects go to clinic, as well, every 6 months to obtain the same measurements as the controls (weight, BMI, % fat, fasting insulin, fasting glucose, lipids, blood pressure).

Eligibility

Ages Eligible for Study:

8 Years to 16 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Ages 8-16 years old

BMI >95th percentile for age/gender based on CDC

Both primary caregiver/parent and child must agree to participate in the nutrition classes

Exclusion Criteria:

endocrinopathies, including hypothyroidism and diabetes

Psychiatric disorders that will interfere with ability to complete follow-up and adherence to protocol

Any behavioral or psychosocial issue that will interfere with subject's completion of program, including eating disorder.

Any use of medication (steroids, for ex.) that contributes to excess adiposity.

Any use of pharmacological intervention for weight management, including prescription medications, over-the-counter medications, or herbal supplements.

Any concurrent membership in a weight management program.

Inability or unwillingness of parent to accompany the child to nutrition classes.

Pregnancy

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00409422